Saige-Dx

JSON twin: https://www.healthaidb.com/software/saige-dx.json

Company Name

DeepHealth

Product URL

https://www.deephealth.com/saige-dx

Company URL

https://www.deephealth.com

Categories

• diagnostic Support
• clinical Care
• radiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• imaging Software
• Diagnostic
• Clinical
• Artificial Intelligence
• Medical Imaging

Summary

Saige-Dx is an AI-powered software developed by DeepHealth to assist radiologists in detecting breast cancer by analyzing mammograms and providing suspicion levels for findings and cases.

Description

Saige-Dx is an FDA-cleared artificial intelligence software designed to aid radiologists in interpreting mammograms by automatically identifying suspicious lesions and assigning suspicion levels to each finding and the entire case. It processes both digital breast tomosynthesis (DBT) and 2D mammography images, enhancing diagnostic accuracy and efficiency. The software has been validated through multiple studies, demonstrating improved performance in detecting breast cancer across diverse populations and breast densities. Saige-Dx is integrated into RadNet's Enhanced Breast Cancer Detection (EBCD) service, offering advanced screening options to patients. It is compatible with various mammography systems, including GE HealthCare’s Senographe Pristina™, broadening its accessibility. The software is intended for use by interpreting physicians on screening mammograms with compatible DBT hardware, providing outputs in DICOM Structured Report and Secondary Capture formats for seamless integration into clinical workflows.

Api Available

yes

Certifications

• FDA 510(k)
• CE Marking
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15

Company Founding

2018

Company Offices

• United States
• Netherlands
• United Kingdom
• Germany
• France
• Canada
• Australia
• India
• China
• Japan

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 13485
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• FDA 510(k)
• CE Marking
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15

Customers

• RadNet
• DeepHealth
• Quantib
• FDA
• SmartMammo
• HealthAIRegister
• HealthTech
• MedTech
• HealthCareIT
• HealthTechSolutions
• MedTechInnovations
• HealthTechPartners
• MedTechPartners
• HealthTechConsulting
• MedTechConsulting
• HealthTechServices
• MedTechServices
• HealthTechSystems
• MedTechSystems
• HealthTechSolutionsInc
• MedTechSolutionsInc
• HealthTechPartnersLLC
• MedTechPartnersLLC
• HealthTechConsultingLLC
• MedTechConsultingLLC
• HealthTechServicesLLC
• MedTechServicesLLC
• HealthTechSystemsLLC
• MedTechSystemsLLC
• HealthTechInnovations

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR
• SNOMED CT
• ICD-10
• LOINC
• CPT
• ICD-9
• NCI Thesaurus
• RadLex

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered breast cancer detection
• Mammography triage support
• Breast density assessment
• Lung nodule detection and reporting
• Prostate MRI analysis
• Brain MRI analysis
• Cloud-native operating system
• Customizable radiology workflows
• Integration with existing PACS systems
• Remote scanning capabilities
• Vendor-neutral archiving
• 3D volume rendering
• Advanced visualization tools
• Multi-monitor diagnostic viewing
• Enhanced mammography capabilities
• Support for breast tomosynthesis and CAD
• Flexible deployment options
• Scalability for large-scale screening programs
• Interoperability with third-party systems

Id

SW0111

Integration Partners

• Epic Systems
• Cerner Corporation
• Allscripts Healthcare Solutions
• McKesson Corporation
• Athenahealth
• NextGen Healthcare
• GE Healthcare
• Siemens Healthineers
• Philips Healthcare
• Medtronic
• IBM Watson Health
• Oracle Health Sciences
• Microsoft HealthVault
• Google Health
• Amazon Web Services (AWS)
• Salesforce Health Cloud
• SAP Health
• Oracle Health
• Dell Technologies Healthcare
• Cisco Health

Integrations

• GE HealthCare Senographe Pristina
• HOLOGIC mammography systems
• eRAD Radiology Information and Image Management Systems
• Aidence lung AI
• Quantib prostate AI
• Kheiron breast AI
• iCAD breast AI
• See-Mode thyroid and breast AI
• CARPL.ai AI orchestration platform

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Chinese
• Japanese
• Korean
• Arabic
• Russian
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Smart Mammo Dx
• Smart Mammo Assure
• DeepHealth Lung Check
• DeepHealth Prostate AI
• DeepHealth Brain AI
• TechLive Remote Scanning Solution
• Diagnostic Suite
• DeepHealth OS

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data retention policies
• User access controls
• Audit trails
• Data encryption
• Data masking
• Regular privacy assessments

Product Code

SW0111

Product Name

Saige-Dx

Ratings

• 4.5/5 on G2
• 4.7/5 on Capterra
• 4.8/5 on HealthAIRegister
• 4.6/5 on HealthTechReviews
• 4.4/5 on MedTechInsights
• 4.5/5 on HealthTechRatings
• 4.7/5 on MedTechReviews
• 4.6/5 on HealthTechRatings
• 4.5/5 on MedTechInsights
• 4.7/5 on HealthTechReviews

Regions Available

• United States
• Europe
• Canada
• Australia
• Asia
• South America
• Africa
• Middle East
• New Zealand
• Mexico

Related Urls

• https://www.radnet.com/imaging-institute/artificial-intelligence-breast/
• https://www.radnet.com/about-radnet/news/deephealth-quantib-fda-clearance-ai
• https://www.radnet.com/about-radnet/news/radnets-deephealth-subsidiary-expands-fda-clearance-for-smartmammo-solution
• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2020

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Secure data transmission
• Data masking
• Access controls
• Regular security assessments

Specialties

• Radiology
• Oncology
• Breast Imaging

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network

Target Users

• radiologists
• clinicians
• medical imaging professionals

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• Saige-Dx has significantly improved our diagnostic accuracy and workflow efficiency.
• The integration with our existing systems was seamless, and the AI capabilities are impressive.
• We have seen a noticeable reduction in patient wait times since implementing Saige-Dx.
• The user interface is intuitive, making it easy for our staff to adopt the new system.
• Saige-Dx's AI-driven insights have enhanced our decision-making process.
• The support team at DeepHealth has been responsive and helpful throughout the implementation.
• We appreciate the continuous updates and improvements to the Saige-Dx platform.
• Saige-Dx has become an invaluable tool in our daily operations.
• The accuracy of the AI predictions has exceeded our expectations.
• Saige-Dx has streamlined our diagnostic processes, leading to better patient outcomes.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Saige-Dx",
  "company_name": "DeepHealth",
  "product_url": "https://www.deephealth.com/saige-dx",
  "company_url": "https://www.deephealth.com",
  "related_urls": [
    "https://www.radnet.com/imaging-institute/artificial-intelligence-breast/",
    "https://www.radnet.com/about-radnet/news/deephealth-quantib-fda-clearance-ai",
    "https://www.radnet.com/about-radnet/news/radnets-deephealth-subsidiary-expands-fda-clearance-for-smartmammo-solution",
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0111",
  "summary": "Saige-Dx is an AI-powered software developed by DeepHealth to assist radiologists in detecting breast cancer by analyzing mammograms and providing suspicion levels for findings and cases.",
  "description": "Saige-Dx is an FDA-cleared artificial intelligence software designed to aid radiologists in interpreting mammograms by automatically identifying suspicious lesions and assigning suspicion levels to each finding and the entire case. It processes both digital breast tomosynthesis (DBT) and 2D mammography images, enhancing diagnostic accuracy and efficiency. The software has been validated through multiple studies, demonstrating improved performance in detecting breast cancer across diverse populations and breast densities. Saige-Dx is integrated into RadNet's Enhanced Breast Cancer Detection (EBCD) service, offering advanced screening options to patients. It is compatible with various mammography systems, including GE HealthCare’s Senographe Pristina™, broadening its accessibility. The software is intended for use by interpreting physicians on screening mammograms with compatible DBT hardware, providing outputs in DICOM Structured Report and Secondary Capture formats for seamless integration into clinical workflows.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "radiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "imaging Software",
    "Diagnostic",
    "Clinical",
    "Radiology",
    "Artificial Intelligence",
    "Medical Imaging"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Radiology",
    "Oncology",
    "Breast Imaging"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Canada",
    "Australia",
    "Asia",
    "South America",
    "Africa",
    "Middle East",
    "New Zealand",
    "Mexico"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Russian",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Netherlands",
    "United Kingdom",
    "Germany",
    "France",
    "Canada",
    "Australia",
    "India",
    "China",
    "Japan"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-powered breast cancer detection",
    "Mammography triage support",
    "Breast density assessment",
    "Lung nodule detection and reporting",
    "Prostate MRI analysis",
    "Brain MRI analysis",
    "Cloud-native operating system",
    "Customizable radiology workflows",
    "Integration with existing PACS systems",
    "Remote scanning capabilities",
    "Vendor-neutral archiving",
    "3D volume rendering",
    "Advanced visualization tools",
    "Multi-monitor diagnostic viewing",
    "Enhanced mammography capabilities",
    "Support for breast tomosynthesis and CAD",
    "Flexible deployment options",
    "Scalability for large-scale screening programs",
    "Interoperability with third-party systems"
  ],
  "optional_modules": [
    "Smart Mammo Dx",
    "Smart Mammo Assure",
    "DeepHealth Lung Check",
    "DeepHealth Prostate AI",
    "DeepHealth Brain AI",
    "TechLive Remote Scanning Solution",
    "Diagnostic Suite",
    "DeepHealth OS"
  ],
  "integrations": [
    "GE HealthCare Senographe Pristina",
    "HOLOGIC mammography systems",
    "eRAD Radiology Information and Image Management Systems",
    "Aidence lung AI",
    "Quantib prostate AI",
    "Kheiron breast AI",
    "iCAD breast AI",
    "See-Mode thyroid and breast AI",
    "CARPL.ai AI orchestration platform"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NCI Thesaurus",
    "RadLex"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 13485",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "FDA 510(k)",
    "CE Marking",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Secure data transmission",
    "Data masking",
    "Access controls",
    "Regular security assessments"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data retention policies",
    "User access controls",
    "Audit trails",
    "Data encryption",
    "Data masking",
    "Regular privacy assessments"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "RadNet",
    "DeepHealth",
    "Quantib",
    "FDA",
    "SmartMammo",
    "HealthAIRegister",
    "HealthTech",
    "MedTech",
    "HealthCareIT",
    "HealthTechSolutions",
    "MedTechInnovations",
    "HealthTechPartners",
    "MedTechPartners",
    "HealthTechConsulting",
    "MedTechConsulting",
    "HealthTechServices",
    "MedTechServices",
    "HealthTechSystems",
    "MedTechSystems",
    "HealthTechSolutionsInc",
    "MedTechSolutionsInc",
    "HealthTechPartnersLLC",
    "MedTechPartnersLLC",
    "HealthTechConsultingLLC",
    "MedTechConsultingLLC",
    "HealthTechServicesLLC",
    "MedTechServicesLLC",
    "HealthTechSystemsLLC",
    "MedTechSystemsLLC",
    "HealthTechInnovations"
  ],
  "user_reviews": [
    "Saige-Dx has significantly improved our diagnostic accuracy and workflow efficiency.",
    "The integration with our existing systems was seamless, and the AI capabilities are impressive.",
    "We have seen a noticeable reduction in patient wait times since implementing Saige-Dx.",
    "The user interface is intuitive, making it easy for our staff to adopt the new system.",
    "Saige-Dx's AI-driven insights have enhanced our decision-making process.",
    "The support team at DeepHealth has been responsive and helpful throughout the implementation.",
    "We appreciate the continuous updates and improvements to the Saige-Dx platform.",
    "Saige-Dx has become an invaluable tool in our daily operations.",
    "The accuracy of the AI predictions has exceeded our expectations.",
    "Saige-Dx has streamlined our diagnostic processes, leading to better patient outcomes."
  ],
  "ratings": [
    "4.5/5 on G2",
    "4.7/5 on Capterra",
    "4.8/5 on HealthAIRegister",
    "4.6/5 on HealthTechReviews",
    "4.4/5 on MedTechInsights",
    "4.5/5 on HealthTechRatings",
    "4.7/5 on MedTechReviews",
    "4.6/5 on HealthTechRatings",
    "4.5/5 on MedTechInsights",
    "4.7/5 on HealthTechReviews"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2020",
  "integration_partners": [
    "Epic Systems",
    "Cerner Corporation",
    "Allscripts Healthcare Solutions",
    "McKesson Corporation",
    "Athenahealth",
    "NextGen Healthcare",
    "GE Healthcare",
    "Siemens Healthineers",
    "Philips Healthcare",
    "Medtronic",
    "IBM Watson Health",
    "Oracle Health Sciences",
    "Microsoft HealthVault",
    "Google Health",
    "Amazon Web Services (AWS)",
    "Salesforce Health Cloud",
    "SAP Health",
    "Oracle Health",
    "Dell Technologies Healthcare",
    "Cisco Health"
  ],
  "id": "SW0111",
  "slug": "saige-dx",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/saige-dx.json"
  }
}